MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 362780

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

Bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for air bubbles in the gel with the incident lot was observed.Additionally, retention samples were selected for evaluation, and the customer's indicated failure mode for air bubbles in the gel was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.

Event Description

It was reported that the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml had air bubbles in the gel.

Manufacturer Narrative

Medical device type is corrected to jcf.Pma / 510(k)# is corrected to k891407.

• Brand Name: BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7468773
• MDR Text Key: 106980579
• Report Number: 1917413-2018-01056
• Device Sequence Number: 1
• Product Code: JCF
• Combination Product (y/n): N
• PMA/PMN Number: K891407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 362780
• Device Lot Number: 5295540
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other